MAUDE Adverse Event Report: AESCULAP AG SENSATION NOIR SCIS S/S BAY CVD 195/70MM; SCISSORS

Model Number FM147B

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that the tip of the sensation noir scissors broke off during surgery.The tip was recovered with no patient harm.There was a five (5) minute delay in surgery.

Manufacturer Narrative

Investigation: the components have been examined visually and microscope with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the instrument.Here we found a broken off tip.Additionally, we found visible damage and quirks.Furthermore, we made a visual inspection of the fracture surface.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: according to the quality standard a material defect and production error can be excluded.No pores or foreign bodies could be found on the point of rupture.Investigations lead to the assumption that the broken off tip was caused by a mechanical overload situation due to an improper handling.There is the possibility of torsion or high leverage with the instrument and also the possibility for pre-damage or similar due to previous surgeries.The visible damage quirks could have been caused due to other instruments.No capa is necessary.

• Brand Name: SENSATION NOIR SCIS S/S BAY CVD 195/70MM
• Type of Device: SCISSORS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7764496
• MDR Text Key: 116537289
• Report Number: 9610612-2018-00349
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM147B
• Device Catalogue Number: FM147B
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/09/2018
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention